Equine-assisted biographical work (EABW) with individuals in the second half of life: study protocol of a multicentre randomised controlled trial
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Schmidt et al. Trials (2020) 21:857
https://doi.org/10.1186/s13063-020-04784-3
STUDY PROTOCOL Open Access
Equine-assisted biographical work (EABW)
with individuals in the second half of life:
study protocol of a multicentre randomised
controlled trial
Julia Schmidt1,2, Andrea Wartenberg-Demand3 and Simon Forstmeier2*
Abstract
Background: Equine-assisted therapy is more often practiced with children and adolescents than with the elderly,
although individuals in the second half of life could also profit from it. This group, from the age of 50, is characterised
by increasing emotional, social, health-related and cognitive changes; a critical life event, such as a neurological illness
or loss of a family member, can increase the likelihood of subclinical depression. Individuals who exhibit depressive
symptoms not necessarily diagnosed with a major depression may suffer from relevant losses of quality of life (e.g.
sleep disorders, memory disorders, feelings of guilt, hopelessness). Despite the fact that the various healthcare systems
are in general more frequently used, such individuals often do not receive adequate therapy. The processing of one’s
biography (reminiscence) is an elementary component of most psychotherapy approaches and has been
demonstrated to treat and prevent the development of major depression. In this study, equine-assisted biographical
work (EABW), a combination of equine-assisted therapy and biographical work, will be applied with individuals with
subclinical depression in the second half of their life.
Methods: This is a multicentre, prospective, randomised, controlled and open phase III study in enrolling participants
with subclinical depression. The aim of the study is to evaluate whether a preventive, equine-assisted, age-specific
treatment combining elements of equine-assisted intervention with those of biographical work offers better treatment
potentials in comparison to a control group with no intervention. Study participants in the intervention group will
receive weekly equine-assisted biographical work over a period of 8 weeks. The primary endpoint is the change in Beck
Depression Inventory-II (BDI-II) in a pre-post comparison. Secondary endpoints include other health-related
questionnaires including quality of life, reminiscence functions and anxiety.
Discussion: The present study is the first randomised study examining the efficacy of biographical work with
a horse and has the potential to establish an empirically based treatment for individuals in the second half of
life and improving the symptoms of subclinical depression.
Trial registration: German Clinical Trials Register DRKS00017010. Registered on 01 April 2019
Keywords: Equine-assisted intervention, Equine-assisted therapy, Biographical work, Reminiscence, Life review,
Second half of life, Subclinical depression, Prevention, Randomised controlled study
* Correspondence: simon.forstmeier@uni-siegen.de
2
Developmental Psychology and Clinical Psychology of the Lifespan, Faculty
II, University of Siegen, Adolf-Reichwein-Str. 2a, 57068 Siegen, Germany
Full list of author information is available at the end of the article
© The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License,
which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give
appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if
changes were made. The images or other third party material in this article are included in the article's Creative Commons
licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons
licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain
permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the
data made available in this article, unless otherwise stated in a credit line to the data.Schmidt et al. Trials (2020) 21:857 Page 2 of 11
Background capabilities using the knowledge gained in this way for
Equine-assisted therapy shaping the future [13]. The use of different methods
The horse as a medium in human interaction is used in (e.g. body and sense methods, timeline work, laying out
various social, pedagogical, therapeutic and medical the lifeline) can trigger processes of memory [14].
areas due to its many and varied factors of influence [1]. The development theory put forward by Erik H. Erik-
The generic term “equine-assisted interventions” in- son is taken as the basis for biographical work [15]. Erik-
cludes, for example, hippotherapy (physiotherapeutic son describes human development as a life-long process
treatment with the horse) and equine-assisted therapy taking place in eight phases—from infancy to late adult-
(EAT), which will be explained further below. These hood [16, 17].
approaches differ from each other in their methodology, The main targets of the biographical work are as fol-
aims and the basic training of the therapist [2]. lows: recall of autobiographical memory contents, raising
EAT is used in combination with psychological set- awareness, recognising own resources, increase of self-
tings. The primary target group of this specific interven- confidence, support in finding identity, development of a
tion are children and adolescents who have a holistic sense of coherence, increase of the well-being, improving
need for therapy [3, 4]. Case studies with adults the quality of life and positive life balance.
discussed in the literature are predominantly EAT for In principle, biographical work can be used both pre-
the treatment of a diagnosed disorder, whereas prevent- ventively and to treat existing mental and physical ill-
ive approaches receive little attention [5]. Older adults nesses. Studies show significant positive effects in the
(i.e. aged 65 and older), in contrast, are for the most part structured use of biographical work to improve general
left out when it comes to equine-assisted therapy, and well-being, in depression [18–20] and in people with de-
only a few study results concerning this group of people mentia [21, 22]. The positive effect of life review in a
are available to date [6]. therapeutic context (reminiscence therapy) was confirmed
EAT has a variety of different aims, such as strength- in a meta-analysis by Pinquart and Forstmeier [23]. They
ening of self-esteem, strengthening of self-confidence, found a large effect size with regard to depressive symp-
support of self-efficacy, managing and reducing fears, toms for life review therapy in older people with a clinical
support of relaxation, identifying resources, improve- depression (g = 1.09) and a moderate effect size for the
ment in problem solving, support for personal develop- pooled sample of all studies (g = 0.57) [23].
ment and improvement of the body sensation.
Well-known studies corroborate the positive effect of Equine-assisted biographical work
equine-assisted interventions on physical development Equine-assisted biographical work (EABW; German: Pfer-
and ability [7] as well as the stabilisation of psychological degestützte Biografiearbeit—Erwachsene, PBA-E) is an in-
well-being [8, 9]. In a meta-analysis carried out by Selby tegration of equine-assisted therapy into biographical
and Smith-Osborne, 14 out of 103 studies were selected work.
to represent the biopsychosocial effects of horses on The recently developed concept, which consists of ele-
humans [1]. One pilot study mentioned in this meta- ments of equine-assisted intervention [24] and biograph-
analysis should be emphasised which showed statistically ical work or life review [15], has been successfully
significant results for depression syndromes (p = .001) investigated in various case studiesstudies (Schmidt J:
for subjects participating in EAT [1, 10]. Pferdegestützte Biografiearbeit mit Menschen in der
Although an increasing number of studies have been zweiten Lebenshälfte, unpublished). Using the horse as a
carried out in the field in recent years, there are only a medium, biographically relevant topics are dealt in a
few significant results confirming the effectiveness of structured way and the different phases of life from
this complementary form of therapy. In most cases, the childhood to adulthood are considered.
results are not valid because the studies were often car- The horse is thus taken in its natural environment and
ried out with too small a sample size or without a con- integrated into a process of structured self-reflection,
trol group [11]. whereby the individual stages of human development
can be highlighted and the resulting experiences learned
Biographical work can be used for resource-oriented future design.
Biographical work is assigned as an independent method Despite the increased number of older adults, espe-
to the umbrella term of life review and is used in various cially preventive approaches for older people have re-
social, educational, nursing, medical and therapeutic age ceived little attention both in equine-assisted prevention
and work contexts [12]. From among the various defini- and practice to date, despite the fact that older individ-
tions of biographical work, it can be summarised that uals may be able to look back on a joint development
this structured form of self-reflection of one’s life serves history with the horse as a working and farm animal. In
to understand the present and to develop resources and equine-assisted therapies, the patient is not expected toSchmidt et al. Trials (2020) 21:857 Page 3 of 11
have any experience in working with horses. In addition, design this multicentre, prospective, randomised, con-
the focus is not on riding, but on equine-assisted work trolled phase III study.
from the ground.
Study objectives
The aim of this multicentre, prospective, randomised,
Older persons and medical condition
controlled and open phase III study is to evaluate
The phase of life from the age of 50 onwards is often
whether a preventive, equine-assisted, age-specific treat-
marked by significant emotional, social, sensory, motor
ment of study participants with subclinical depression,
and cognitive changes. In addition, people in this age
combining elements of equine-assisted intervention with
group often experience critical life events, e.g. the loss of
those of biographical work, offers better treatment po-
loved ones, relationship problems, changes in the work-
tentials in comparison to a control group with no
place, poverty and occurrences of diseases [25]. These fac-
intervention.
tors are even more important in view of the ongoing
demographic change. These burdens can contribute to the
Methods/design
development of subclinical depression, i.e. depressive
Design
symptoms manifest themselves, but are not so severe as to
This is a multicentre, prospective, randomised, con-
justify the diagnosis of clinically relevant major depression.
trolled and opened phase III study which includes par-
If major depression is defined according to the DSM-V,
ticipants with symptoms of subclinical depression.
the person must be experiencing five or more symptoms
Those will be randomly assigned to either the interven-
(e.g. significant weight loss, fatigue or loss of energy nearly
tion or the control group.
every day, recurrent thoughts of death) during the same 2-
Study participants in the intervention group will re-
week period and at least one of the symptoms should be
ceive weekly EABW sessions over a period of 8 weeks.
either (1) depressed mood or (2) loss of interest or pleas-
According to the study protocol, weekly visits may only
ure [26]. However, subclinical depression is very often as-
take place in a time window of more or less than 3 days.
sociated with a poorer quality of life and greater need for
Participants in the control group will undergo no inter-
assistance from the healthcare system [27, 28]. In addition,
vention. This control group is chosen because it repre-
(subclinical) depression can be difficult to diagnose.
sents the standard since individuals with subclinical
Affected individuals might contact healthcare providers
depression seldomly undergo a treatment. Nonetheless,
for various somatic symptoms or complaints before final
participants in the control group will be offered a min-
diagnosis is known [29]. Previous studies in subclinical de-
imal intervention consisting of 3 units after the follow-
pression with psychological treatments such as cognitive-
up period. Follow-up assessments will take place 3
behavioural therapy (CBT) have shown moderate effects
months after the intervention.
in treating such symptoms [30].
The primary endpoint is the change in Beck Depres-
sion Inventory-II (BDI-II) in a pre-post comparison that
Rationale for the current study will be taken directly before the first and after the last
At this point, EABW can be applied to individuals who intervention.
may do not have access to psychotherapeutic treatment The revised version of the Beck Depression Inventory
due to missing treatment options. EABW could be a is a self-assessment questionnaire that is used to clarify
measure to support those individuals. In addition, and diagnose the course of depression. The question-
EABW has the potential to motivate those that are not naire consists of a total of 21 items (e.g. “feelings of
inclined to accept psychotherapy. guilt”, “crying”, “loss of interest”). The study participant
Due to the low level of knowledge in this field of can select four possible answers from 19 items that de-
research, a pilot study has been undertaken (Schmidt scribe their state of mind within the last 14 days up to
J: Pferdegestützte Biografiearbeit mit Menschen in der the present (e.g. “sadness”: (0) “I am so sad”, (1) “I am
zweiten Lebenshälfte, unpublished). The concept was often sad”, (2) I am sad all the time, (3) “I am so sad or
developed using a descriptive questionnaire survey unhappy that I cannot stand it”). Two items (“change in
among therapists (N = 100). Additionally, a case study sleeping habits”, “Change in appetite”) provide seven
(N = 2) on EABW with individuals in the second half possible answers by increasing or decreasing the symp-
of life was carried out. In an uncontrolled pretest- toms. Limit values for the BDI-II are as follows: 0–8: no
posttest design, the effects were measured using a depression, 9–13: minimal depression, 14–19: mild de-
clinical questionnaire battery. The measured positive pression, 20–28: moderate depression and 29–63: severe
effects of the individual case study indicate that depression [32].
EABW contributes to a measurable stabilisation of The German BDI-II demonstrates good reliability and
psychological well-being [31] and served as a basis to validity in clinical and nonclinical samples [33, 34].Schmidt et al. Trials (2020) 21:857 Page 4 of 11
Secondary endpoints include other health-related and free work, accustoming the horse to different mate-
questionnaires (e.g. quality of life, reminiscence and anx- rials, a comprehensive relaxation training and a balance
iety). Study participants are seen by the therapist at the training [37, 38].
regular basis. Relevant is the comparison between base- In order to be able to ensure a high-quality interven-
line and week 8 (primary endpoint). We consider further tion, the following criteria will be examined before a site
information in the text as too extensive, but they are is included in the study: horse husbandry, feeding, move-
available in the figure (SPIRIT schedule). ment areas, constitution of the therapy horses, stables,
Due to the use of the horse, neither the therapist nor horse training and education, riding facility and ancillary
the study participant can be blinded. While the investi- rooms and safety protocols and facilities.
gator who is responsible for the randomisation is not
blind for group assignment, the statisticians who are re- Recruitment
sponsible for statistical analysis will be blind. Each study centre is responsible for recruiting partici-
pants. The therapists will receive materials for the re-
Study sites cruitment of study participants that have been approved
Participants will be recruited at 13 locations in Germany. by the Ethics Committee. In the meanwhile, active ad-
The list of study sites and all relevant documents will be vertisements for study participation will be circulated,
managed by the study coordinator and included in the e.g. in the community and at medical practices.
trial master file. The therapist at each site is the respon-
sible contact person and must be familiar with all the Participants
guidelines of the professional association for equine- The following eligibility criteria were selected to include
assisted intervention in Germany (www.berufsverband- participants of either sex with subclinical depression.
pi.de) and the guidelines “Quality assurance for equine- We decided to use the Beck Depression Inventory-II
assisted interventions” [35, 36]. (BDI-II) to define subclinical depression and the Struc-
The following criteria must be fulfilled to qualify as a tured Clinical Interview for DSM-5® Disorders—Clinical
therapist: Version (SCID-5-CV) to exclude major depression. The
following inclusion and exclusion criteria are reviewed
– Basic educational, psychological, therapeutic or by the therapist.
medical profession
– Appropriate equestrian qualification (riding badge Inclusion criteria
and lunging badge)
– Recognised further training in the field of equine- 1. Age ≥ 50
assisted intervention 2. Symptoms of subclinical depression (BDI-II ≥ 9)
– Participation in a 1-day training course on EABW 3. Sufficient physical and mental resilience
and conducting a study according to the Inter- 4. Adequate language skills
national Conference on Harmonisation-Good Clin- 5. Written informed consent
ical Practice (ICH-GCP) guidelines
Exclusion criteria
The central medium in EABW is the specially trained
horse (which undergo a training according to conven- 1. Equinophobia
tional riding therapy or riding pedagogy); the consider- 2. Severe horse hair allergy
ation of animal welfare is therefore essential for this 3. Diagnosis of major depression based on SCID-5-CV
study. Only physically and mentally healthy animals are 4. Acute suicidal tendency
used. Each therapist has to be responsible for keeping 5. Psychotic disorders known from anamnesis
the horse healthy according to animal protection law, 6. Known dementia
and no additional veterinary care is provided by the 7. Known severe systemic diseases (e.g. cancer and
sponsor. It is known that all therapists are members of Parkinson’s disease)
the professional association for equine-assisted interven- 8. Intake of chemical or herbal antidepressants
tion in Germany; therefore, a quality assurance is given, 9. Participation in psychotherapeutic treatment 4
also with regard to the well-being of the horses. The weeks before or during the study (including
sites will be inspected during regular monitoring visits follow-up)
by a well-trained and educated monitor. 10. Participation in another study within the last 30
The essential building blocks of horse training include days before inclusion
a solid basic training in riding, the use of various leading 11. Employment by the therapist
and lunging techniques, the use of classical ground work 12. Familial relation to the therapistSchmidt et al. Trials (2020) 21:857 Page 5 of 11
Withdrawal criteria participate in the study at any time without giving rea-
Participation in the study is optional, and there are no sons and must not be led to expect any adverse
negative consequences for refusing participation or consequences.
dropping out. In order to minimise discontinuation The study participant must sign and personally date
rates, the participants will be informed in detail about the informed consent form for participation in the study
the study in written and oral form in advance. The ther- before any study-related procedures are performed. Per-
apist, in consultation with the study coordinator, may sons who cannot give their informed consent will not be
decide if it is necessary to discontinue the study for a included in the study. The written informed consent
specific study participant. The reason for termination form is then to be filed and retained by the therapist at
must be documented in a case report form (CRF). the trial site. A duplicate of the signed and dated written
The study participant may withdraw or be excluded informed consent form must be given to the study
from the study if: participant.
– The written informed consent is revoked Randomisation
– A drug treatment with antidepressants is indicated After giving their informed consent, participants will
– Any UEs, laboratory abnormalities and medical or undergo a screening visit, after which the therapist will
psychological conditions would be detrimental or send the screening documents in encrypted form to the
harmful to the study participant if the intervention study coordinator. The coordinator will then check the
were continued documents for completeness in advance and forwards
– Progression or occurrence of a disease that requires them to the study director for randomisation. Partici-
discontinuation of the study pants need to meet all requirements for participation in
– Significant protocol deviations that require the study in order to be randomised. The allocation ratio
termination of the study for randomisation into either the “intervention group” or
– An exclusion criterion occurs subsequently the “control group” is 1:1. A randomisation list was cre-
– A lack of compliance is apparent ated using the software RandList (http://randomisation.
– The contact to the study participant is lost eu) before the start of the study. The therapist shall re-
– It is a request of the study participant ceive written confirmation of the group to which the
study participants have been assigned. The pre-test sur-
Participants could inform their general practitioner vey begins at the earliest on the following day, at the lat-
based on an information letter, which they get from est 30 days after randomisation.
the therapist, about the study participation. The ac-
companying medication, which is indicated due to Interventions
other basic illnesses, can be further taken by the Study participants assigned to the intervention group
study participant. With study inclusion, concomitant will receive 8 sessions of EABW (90 min each) for ap-
medication will be documented. If after inclusion in proximately 8 weeks. Immediately before the first and
the study additional therapies/treatments are neces- after the last intervention, they will be asked about their
sary, these are to be communicated to the therapist psychological and health status using a battery of ques-
and it is to be decided whether the study can be con- tionnaires. Before and after the interventions, short
tinued. If possible, the existing concomitant medica- questionnaires will be applied in order to find out the
tion should be continued unchanged during the current psychological state of the study participants.
study. No chemical or herbal antidepressants should Three months after the last intervention, a follow-up
be taken during the study. If this is medically neces- survey will be carried out.
sary or accidentally done, it must be documented as a Study participants assigned to the control group will
protocol violation. In addition, no psychotherapeutic receive no intervention. The same battery of question-
treatment should be given during the study. naires will be applied at randomisation and 8 weeks later.
After 3 months, the participants complete the follow-up
Informed consent test and may receive 3 minimal interventions of EABW.
The study participants will be informed about the study The first two sessions are scheduled to last 45 min; the
in accordance with GCP and ethical requirements. The last session will last 90 min. Short questionnaires will
study, its objectives, potential benefits and risks and its also be collected before and after the intervention.
consequences will be discussed in detail with the study Study participants will be regularly seen by the therap-
participants orally by the therapist. Sufficient time is to ist. After each visit, a date for the next visit will be
be allowed to read the written information and ask ques- agreed upon. The study participants will be contacted
tions. The study participants may decide not to before the next visit in order to guarantee complianceSchmidt et al. Trials (2020) 21:857 Page 6 of 11
with the protocol. They are informed about the import- PP: All randomised trial participants who were treated
ance of following the exact protocol. It will be avoided according to the protocol underwent the study without
to modify the intervention; however, if there is a need to serious protocol violations and for whom the post-test
modify the intervention, this will be discussed with the measurement could be performed.
steering committee case by case. Changes to the proto- SAS: All study participants who have received at least
col will be documented as minor or major protocol devi- one of the eight therapy units.
ations. Furthermore, regular phone calls will be held All statistical evaluations are performed with IBM
with the therapists. If necessary, re-trainings will be per- SPSS Statistics 25 (2017). A two-sided significance level
formed. The therapists have received audio files on the of 5% applies to all tests.
performance of each intervention. A simple analysis of variance (ANOVA) with repeated
The interventions within EABW follow a standar- measurements (pre-test, post-test) will be performed to
dised concept (Table 1), which the therapist must compare the mean change in depressive symptoms up to
comply with. the post-test in both groups (factor). In a supplementary
analysis of covariance (ANCOVA), the gender, age and
severity of depressive symptoms are statistically con-
Statistical analysis trolled as covariates.
All statistical methods used for the final analysis are de- A further single factor analysis of variance with re-
scribed in the study protocol and were detailed in the peated measurement (pre-test, post-test, follow-up) and
statistical analysis plan. an analysis of covariance are calculated to compare the
The primary target value is the BDI-II for post-testing. mean change in depressive symptoms until follow-up in
The primary analysis is calculated by the full analysis set both groups.
(FAS), and additional analyses are calculated by the per- A multivariate analysis is used to jointly examine the
protocol set (PP). In addition, the safety analysis is per- effects of the intervention on the secondary targets. In
formed with the safety analysis set (SAS). Missing values this way, correlations between the targets are taken into
will be imputed through the last observed value (last ob- account. Post hoc analyses are performed after a signifi-
servation carried forward (LOCF)). FAS: All study partic- cant overall effect has been found.
ipants who have been randomised (“as randomised”)
received at least one intervention and underwent BDI-II
baseline testing. These study participants are included in Methods to prevent bias
the analysis regardless of protocol violations and therapy The proposed study requires several methods to prevent
termination. bias.
Table 1 Description of sessions
No. Unit Focus Topic
1 Childhood I Familiarisation with habitat - Exploration of the horse’s habitat
- Triggering of childhood memories
- Possible use of nostalgic objects
2 Childhood II Relationship work - Relationship building with the horse through body-oriented work
- Exploration of the horse’s body
- Use of a massage technique
- Preparation of the lifeline part 1
3 Adolescence I Constellation task - Demonstration of relationships with the help of the horse
- Use of horse figures as representatives for family relationships
4 Adolescence II Communication - Observing and naming the non-verbal communication of horses
- Naming of characteristics of difficult human communication
- Preparation of the lifeline part 2
5 Young adulthood Self-assertion training - Experiences and dealing with stress
- Guiding rope work
- Positioning
6 Adulthood I Parcourse work - Experiencing and accepting challenges
- Dealing with obstacles, formulation of objectives
7 Adulthood II Mindfulness training - Recognising and naming one’s own needs
- Preparation of the lifeline part 3
8 Integration Gain of knowledge - Collecting findings from the previous units
- Response to open questions
- Review of the complete lifelineSchmidt et al. Trials (2020) 21:857 Page 7 of 11
Selection bias The randomisation procedure is the gold long-term archiving will be done in the data repository
standard to avoid this bias. Random numbers will there- of the ZIMT.
fore be generated in advance. The randomisation pro- The data and all associated documentation will be
cedure will be controlled by comparing the two groups stored for a minimum of 10 years after the completion
with regard to possible confounders, i.e. age at the time of the study, including the follow-up period.
of trauma, gender, educational level, diagnosis, cognitive
status and trauma severity. Sample size
The sample size is based on a calculation with G*Power
Detection bias The baseline assessment is done before 3.1 [39]. With a medium effect strength (based on the
randomisation to avoid this bias. meta-analysis of Cuijpers et al. [30], on psychotherapy
for subclinical depression), α = 0.05, a test strength of 1
Performance bias To counteract this bias, the standard- − β = 0.80 and a correlation between repeated measure-
isation procedure (manual, extensive training, documen- ments of r = 0.6, the total sample size is n = 42. With an
tation of sessions, supervision) is established. assumed drop-out rate of 20%, the total sample size is
n = 52 (i.e. 26 persons in each group).
Attrition bias Statistical analysis will include techniques
to minimise possible attrition bias, i.e. intention-to-treat Primary and secondary endpoints
analysis and imputing missing data. In case of drop-outs, The primary target parameter is the improvement of
it is intended to continue data collection whenever subclinical depression after 8 weeks as measured by the
possible. BDI-II.
The BDI-II is a self-assessment questionnaire used to
Handling of missing values and drop-outs examine and diagnose the course of depression. All 21
A complete data set is available if all three test times items (e.g. “feelings of guilt”, “crying”, “loss of interest”)
(pre-test, post-test, follow-up) have been performed. A are measured on a 4-point Likert scale, and higher
drop-out can occur if the participant (1) does not scores represent more severe levels of depression. The
complete the pre-test, (2) decides after information or questionnaire asks about the mental state of the study
after randomisation against participation or (3) starts participant during the last 14 days including up to the
with the treatment, but discontinues it. survey date [40].
If less than 20% of the items of one self-report instru- The secondary target parameters include question-
ment are missing, missing values are imputed by the naires dealing with anxiety, behavioural avoidance, ego
mean of the scale of this participant. If a whole scale is integrity, positive and negative spontaneous thoughts,
missing, the value will be imputed by the expectation- gratitude, general self-efficacy expectation, reminiscence
maximation (EM) algorithm. functions, state of health and mood state.
All questionnaires are processed in printed form. The
Data handling participant timeline is presented as SPIRIT schedule
There are three types of data that is developed or col- (Fig. 1).
lected in this study: the EABW manual, the “life book”
and the assessment data (pre, post and follow-up). The Adverse events
EABW manual will be published with the aim to give Furthermore, the adverse events (AEs) and serious ad-
professionals with adequate training a resource. verse events (SAEs) are recorded and documented as
The life book is a folder that the patient fills with pho- safety parameters. Adverse events are illnesses, signs of
tos, important written (positive and negative) memories disease, symptoms and incidents that occur after inclu-
from all life phases, helpful thoughts, personal and social sion of the participants in the study, but are not neces-
strengths, information about the family etc. This life sarily causally linked to the study.
book will remain in the possession of the participants In addition, the severity of the adverse event is
and will not be analysed. It is a by-product of the defined.
therapy.
The assessment data (information on symptoms) must – Non-serious AEs: All such events, whether expected
be considered very sensitive data. Therefore, the data or not, will be recorded.
will be stored in an anonymous form. Storage and – Serious AEs: The therapist is obliged to inform the
backup will be ensured during the project by the spon- study coordinator within 24 h of the occurrence or
sor in cooperation with the representative of the IT de- suspicion of an SAE. The coordinator reports the
partment of the Centre for Information and Media SAE to the Study Committee and the Ethics
Technology (ZIMT) of the University of Siegen. The Committee.Schmidt et al. Trials (2020) 21:857 Page 8 of 11 Fig. 1 The participant timeline
Schmidt et al. Trials (2020) 21:857 Page 9 of 11
The therapist will assess whether the event is: Treatment of subclinical depression is absolutely rele-
vant, due to the increased mortality, the worse quality of
– Related: There is a comprehensible relationship life of those affected and the increased strain on the
between participation in the study and AE. healthcare system resulting in higher costs [45].
– Not related: There is no traceable relationship To date, little research has been done and no research
between participation in the study and AE. results are known on equine-assisted therapy (EAT) with
adults and seniors suffering from subclinical depression
Data management and quality assurance combining biographical work with the horse.
The mental state is measured using a clinical question- The indications that are treated in equine-assisted in-
naire battery. In addition to the theoretical background terventions in a supportive way are manifold, and more
for the development of the respective instrument, compre- and more studies are being conducted in this area which
hensive interpretation guidelines and information on the show positive physical and psychosocial effects [2]. For
quality criteria are available for the questionnaires used. In example, horses are used for the treatment of individuals
order to check the manageability and applicability of the with post-traumatic stress disorders [8, 46] or autism
manual as well as the feasibility of the intervention, the [47]. However, studies such as these generally still have
therapist shall receive a separate questionnaire. some limitations (e.g. too small sample size, missing
All data will be collected in paper-based CRFs. The control group, no adequate statistics, no randomisation).
sponsor will ensure data validation, data verification and The aim of this study is to investigate the effects of
compliance through regular monitoring visits according equine-assisted biographical work (EABW) in partici-
to ICH-GCP. The therapist is obliged to allow the per- pants with subclinical depression in their second half of
son carrying out the monitoring task (auditor) access to life, because there is a limited number of alternative
the study material necessary to evaluate the study treatment options and preventive measures for individ-
process. Data protection must be guaranteed according uals in this group are especially important. EABW is not
to national law. intended to replace conventional psychotherapeutic or
After the initiation visit, regular visits will be per- drug treatment, but rather help older individuals to
formed by the auditor followed by a final visit at the end identify existing resources by means of a structured re-
of the study. Additionally, the auditor will maintain con- view of their own lives with the help of a horse. The idea
tact with the therapist throughout the term of the study. is to promote self-efficacy and enable a positive life
The data and all appropriate documentation will be balance.
kept for a minimum of 15 years after the completion of The concept of EABW is aimed specifically for profes-
the study, including the follow-up period. sionals from the educational or therapeutic field who
would like to work preventively with people in the sec-
Insurance ond half of life including horses in individual settings.
The study participants are insured by the insurance of Extensive training as well as regular and intensive
the University of Siegen (policy number: H34191780). monitoring and follow-up training will be carried out
Additionally, a commuting accident insurance has been with the therapists involved, e.g. concerning confidenti-
taken out (policy number: 50077572427). ality in dealing with participation data. Furthermore,
telephone conferences will be held and audio files made
Discussion available for each intervention to strengthen compliance
“Depression in the elderly is often underestimated” is and the quality of the study.
the title of an article in the Deutsche Ärzteblatt (German The sample size in the present study is considered ad-
medical journal), which is based on a survey by Stiftung equate to allow for a demonstration of statistical super-
Deutsche Depressionshilfe (German Depression Aid iority of equine-assisted intervention.
Foundation) [41]. It claims that subclinical depression is The primary endpoint concerning the study is taken
a common occurrence among the elderly and that it is by a validated questionnaire. This constitutes a patient-
associated with a significant health restriction as well as reported outcome measure not influence by the
an impairment of quality of life. The prevalence of sub- therapist.
clinical depression in adults is at about 10% in Germany, The design of the study is only limited since a placebo
whereas women have a significantly higher prevalence control is not possible. Due to the use of the horse, nei-
with 11.6% than men with 8.6% [42]. Only 12% of per- ther the investigator nor the study participant can be
sons > 70 has the opportunity to participate in psycho- blinded.
therapeutic treatment [43]. It is alarming that according In order to implement equine-assisted interventions, it
to the survey, the suicide rate in older ages is about five seems to be necessary for therapists to receive equip-
times higher than in younger adults [44]. ment that is intended for individuals from the secondSchmidt et al. Trials (2020) 21:857 Page 10 of 11
half of life onwards and their handling of the horse. Berleburg, Germany; REWE-Markt Heidrich oHG, Erndtebrück, Germany;
Therefore, it is planned that the manual on EABW with Gesundheitszentrum Erndtebrück Nina Völkel-Böhl, Erndtebrück, Germany;
Zahnarztpraxis Dr. Schwarz, Bad Laasphe, Germany; Praxis LebensWege,
individuals in the second half of life will be published Wachtendonk, Germany; Strohm Hufbeschlagsartikel, Düsseldorf, Germany;
and that training courses for professionals in equine in- Schleich GmbH, Schwäbisch Gmünd, Germany; and Loesdau GmbH & Co.
terventions will be offered. In view of the demographic KG, Binsingen, Germany. Open Access funding enabled and organized by
Projekt DEAL.
change in society, EABW offers an opportunity to ex-
pand the range of equine-assisted interventions offered Availability of data and materials
by professionals in the long term. The data from this study will be published in peer-reviewed journals. After
the publication of the results, the dataset which will be used and/or analysed
in the current study as well as statistical codes will be available from the cor-
Trial status responding author on reasonable request. The trial registry will be updated if
Based on protocol version 2.0 (date 22 March 2019). protocol modifications are made.
The trial is in the recruiting phase at the time of manu-
Ethics approval and consent to participate
script submission. The first study participant was re- The study is registered in the German Clinical Trial Register under DRKS00017010
cruited in June 2019, and it is planned that the last and will be conducted in accordance with principles enunciated in the current
participants will join by July 2020. Declaration of Helsinki (DoH) and the guidelines of Good Clinical Practice (GCP)
issued by the International Conference on Harmonisation (ICH). Ethics approval has
Abbreviations been obtained for the study, and any amendment will be duly submitted for
AE: Adverse event; ANCOVA: Analysis of covariance; ANOVA: Analysis of approval. Approved protocol amendments are forwarded to the therapists, and they
variance; BAI: Beck Anxiety Inventory; BDI-II: Beck Depression are trained accordingly when it comes to conducting the study. The trial registry and
Inventory—revision; BPSR-P: Bern Post Session Report—patient version; the Ethics Committee will be informed accordingly.
BPSR-T: Bern Post Session Report—therapist version; CBAS: Cognitive Participation in the study is voluntary, and the participants will be informed
Behavioural Avoidance Scale; CBT: Cognitive-behavioural therapy; CRF: Case of the study conditions in detail and an opportunity will be given to discuss
report form; DORI®E: Documentation and observation sheet for therapeutic and clarify specific questions. Ethical challenges may arise as a result of
and pedagogical interventions (adult version); DoH: Declaration of Helsinki; randomisation. However, the control group is offered a minimal intervention
DSM-V: Diagnostic and Statistical Manual of Mental Disorders; EAT: Equine- consisting of 3 units after the follow-up period.
assisted therapy; EABW: Equine-assisted biographical work; EI: Ego-integrity The study participants are informed that their disease- and personal data will
questionnaire; FAG: Questionnaire for positive and negative spontaneous be stored in pseudonymized form and used for scientific evaluation. The
thoughts; FAS: Full analysis set; GCP: Good Clinical Practice; GQ-6: Gratitude study participants have the right to be informed about the stored data. The
Questionnaire; GREAT: German Research Center for Equine Assisted Therapy; therapists sign a self-commitment for confidentiality.
GSE: General self-efficacy expectation; ICH: International Conference on
Harmonisation; MDMQ: Multidimensional Mood State Questionnaire; PBA- Consent for publication
E: Pferdegestützte Biografiearbeit—Erwachsene; PP: Per-protocol set; RFS- Not applicable.
28: Reminiscence Functions Scale; SAE: Serious adverse event; SAS: Safety
analysis set; SCID-5-CV: Structured Clinical Interview for DSM-5® Disorder- Competing interests
s—Clinical Version; SF-36: Short Form (36); ZIMT: Centre for Information and The authors declare that they have no competing interests.
Media Technology
Author details
1
Acknowledgements Reittherapie Wittgenstein, Pulvermühle 3, 57319 Bad Berleburg, Germany.
2
We would like to thank all study participants, the therapists and our financial Developmental Psychology and Clinical Psychology of the Lifespan, Faculty
supporters. II, University of Siegen, Adolf-Reichwein-Str. 2a, 57068 Siegen, Germany.
3
Schrecksbach, Germany.
Authors’ contributions
JS designed the manual, carried out the pilot study, coordinated the study Received: 9 March 2020 Accepted: 5 October 2020
procedures, trained and advised the therapists in all study matters, carried
out the monitoring in the study centre and is responsible for the evaluation
of all equine therapeutic processes. SF reviewed the manual, is directing the References
study design, randomises the study participants and is responsible for 1. Selby A, Smith-Osborne A. A systematic review of effectiveness of
statistical evaluation and psychological counselling and assessment. AWD is complementary and adjunct therapies and interventions involving equines.
advising on the ICH-GCP guidelines and supporting the monitoring process Health Psychol. 2013;32(4):418–32. https://doi.org/10.1037/a0029188.
and is responsible for medical consultation. The study protocol was 2. White-Lewis S. Equine-assisted therapies using horse healers: a concept
reviewed, commented on, read and approved by all authors. Additionally, all analysis. Nurs Open. 2020;7(1):58–67. https://doi.org/10.1002/nop2.377.
authors will participate as co-authors of the final project report. The sponsor 3. Tsantefski M, Briggs L, Griffiths J, Tidyman A. An open trial of equine-
of the study is the University of Siegen. The study is led by SF who is a pro- assisted therapy for children exposed to problematic parental substance
fessor at this university, and the study is coordinated by JS who received a use. Health Soc Care Commun. 2017;25(3):1247–56.
scholarship from the University of Siegen. The steering committee is com- 4. Holmes CM, Goodwin D, Redhead ES, Goymour KL. The benefits of equine-
posed of the three authors. assisted activities: an exploratory study. Child Adolescent Social Work. 2012;
29(2):111–22.
Funding 5. Dettling M, Opgen-Rhein C, Kläschen M. Praxis Pferdegestützter Therapie
The study is funded by state resources, foundation grants and monetary and bei psychischen Störungen. In: Opgen-Rhein C, Kläschen M, Dettling M,
in-kind donations. There will be no separate data monitoring committee. The editors. Pferdegestützte Therapie bei psychischen Erkrankungen. Stuttgart:
data will be monitored by the steering committee which is independent of Schattauer Verlag; 2011. p. 77–146.
the funding agencies. We would like to thank Rittal Foundation/Rittal GmbH 6. Baldwin AL, Rector BK, Alden AC. Effects of a form of equine-facilitated
& Co. KG, Herborn, Germany; J.J. Darboven GmbH & Co. KG, Hamburg, learning on heart rate variability, immune function, and self-esteem in older
Germany; Bürgerstiftung Siegen, Siegen, Germany; Förderverein des Zen- adults. People and Animals: The International Journal of Research and
trums Therapeutisches Reiten - Niederrhein e.V., Straelen, Germany; LVM - Practice. 2018;1(1):1–17 http://docs.lib.purdue.edu/paij/vol1/iss1/5.
Versicherungsagentur Christian Walczok, Bad Laasphe, Germany; Breuer 7. Vermöhlen V, Schiller P, Schickendantz S, Drache M, Hussack S, Gerber-Grote
GmbH, Bad Laasphe, Germany; BÖHL-Kunststofftechnik GmbH & Co. KG, Bad A, et al. Hippotherapy for patients with multiple sclerosis: a multicenterSchmidt et al. Trials (2020) 21:857 Page 11 of 11
randomized controlled trial (MS-HIPPO). Mult Scler J. 2018;24(10):1375–82. 31. Schmidt J, Gomolla A. Auswirkung der Reittherapie auf die psychische
https://doi.org/10.1177/1352458517721354. Befindlichkeit von Patienten mit neurologischen Erkrankungen. Mensch und
8. Romaniuk M, Evans J, Kidd C. Evaluation of an equine-assisted therapy Pferd international. Zeitschrift für Förderung und Therapie mit dem Pferd.
program for veterans who identify as ‘wound, injured or ill’ and their 2012;4:148–52.
partners. PLoS ONE. 2018;13(9):e0203943. 32. Hautzinger M, Keller F, Kühner C. BDI-II. Beck-Depressions-Inventar. Revision.
9. Kemp K, Signal T, Botros H, Taylor N, Prentice K. Equine facilitated therapy 2th. ed. Frankfurt: Pearson Assessment; 2009.
with children and adolescents who have been sexually abused. A program 33. Kühner C, Bürger C, Keller F, Hautzinger M. Reliabilität und Validität des
evaluation study. J Child Fam Stud. 2014;23(3):558–66. https://doi.org/10. revidierten Beck-Depressionsinventars (BDI-II). Befunde aus
1007/s10826-013-9718-1. deutschsprachigen Stichproben. Nervenarzt. 2007;78(6):651–6. https://doi.
10. Graham JR. An evaluation of equine-assisted wellness in those suffering org/10.1007/s00115-006-2098-7.
from catastrophic loss and emotional fluctuations. Dissertation Abstracts 34. Beck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory-II.
International Section A: Humanities and Social Sciences. 2017;68(3-A):891. San Antonio, TX: Psychological Corporation; 1996.
11. Kendall E, Maujean A, Pepping CA, Downes M, Lakhani A, Byrne J, et al. A 35. Institut für Pferdegestützte Therapie. Leitfaden Qualitätssicherung für
systematic review of the efficacy of equine-assisted interventions on pferdegestützte Interventionen. https://www.ipth.de/wp-content/uploads/
psychological outcomes. Eur J Psychother Counselling. 2015;17(1):57–79. IPTh_-Qualitaetsrichtlinien.pdf. Accessed 21 Jan 2020.
https://doi.org/10.1080/13642537.2014.996169. 36. European Society for Animal Assisted Therapy (2012). The European Society
12. Maercker A. Formen des Lebensrückblicks. In: Maercker A, Forstmeier S, for Animal-Assisted Therapy (ESAAT) guidelines on quality assurance in
editors. Der Lebensrückblick in Therapie und Beratung. Berlin: Springer- animal-assisted therapy. https://www.en.esaat.org/fileadmin/_migrated/
Verlag; 2013. p. 25–45. content_uploads/guidelines_on_quality_assurance_in_animal-assisted
13. Gaggioli A, Scaratti C, Morganti L, Stramba-Badiale M, Agostoni M, Spatola therapy.pdf. Accessed 21 Jan 2020.
CAM, et al. Effectiveness of group reminiscence for improving wellbeing of 37. Kläschen M. Ausbildung des Therapiepferdes. In: Opgen-Rhein C, Kläschen
institutionalized elderly adults: study protocol for a randomized controlled M, Dettling M, editors. Pferdegestützte Therapie bei psychischen
trial. Trials. 2014;15:408. https://doi.org/10.1186/1745-6215-15-408. Erkrankungen. Stuttgart: Schattauer Verlag; 2011. p. 37–53.
14. Ruhe HG. Praxishandbuch Biografiearbeit. Methoden, Themen und Felder. 38. Westermann K. Ganz praktisch: Die Ausbildungsskala für Therapiepferde im
Weinheim: Beltz Juventa; 2014. Alltag. Mensch und Pferd international. Zeitschrift für Förderung und
15. Haight BK, Haight BS. The handbook of structured life review. Baltimore: Therapie mit dem Pferd. 2015;2:48–57.
Professions Press; 2007. 39. Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical
16. Erikson EH. Der vollständige Lebenszyklus. 9th ed. Frankfurt am Main: power analysis program for the social, behavioral and biomedical sciences.
Suhrkamp Taschenbuch; 2016. Behav Res Methods. 2007;39(2):175–91.
17. Erikson EH. Identität und Lebenszyklus. 27th ed. Frankfurt am Main: 40. Beck AT, Steer RA, Ball R, Ranieri WF. Comparison of Beck Depression Inventories-IA
Suhrkamp Taschenbuch; 2015. and -II in psychiatric outpatients. J Pers Assess. 1996;67(3):588–97.
18. Bohlmeijer ET, Kramer J, Smith F, van Marwijk H. The effects of integrative 41. Bundesärztekammer (Arbeitsgemeinschaft der deutschen Ärztekammer) und
reminiscence on mastery and depression. J Commun Mental Health. 2009; Kassenärztliche Bundesvereinigung. Depressionen bei älteren Menschen
45:476–84. unterschätzt. 2019. https://www.aerzteblatt.de/nachrichten/107685/
19. Preschl B, Maercker A, Wagner B, Forstmeier S, Baños RM, Alcañiz M, et al. Depressionen-bei-aelteren-Menschen-unterschaetzt. Accessed 21 Jan 2020.
Life-review therapy with computer supplements for depression in the 42. Brettschneider J, Kuhnert R, Hapke U. Depressive Symptomatik bei
elderly: a randomized controlled trial. Aging Ment Health. 2012;16(8):964–74. Erwachsenen in Deutschland. J Health Monit. 2017;2(3):81–8. https://doi.org/
10.17886/RKI-GBE-2017-058.
20. Bohlmeijer ET, Westerhof GJ. Life review as a way to enhance personal
43. Stiftung Deutsche Depressionshilfe. Depression im Alter. https://www.
growth in midlife: a case study. Int J Reminiscence Life Rev. 2013;1(1):13–8.
deutsche-depressionshilfe.de/depression-infos-und-hilfe/depression-in-
21. Huang HC, Chen YT, Chen PY, Hu SHL, Liu F, Kuo YL, Chiu HY. Reminiscence
verschiedenen-facetten/depression-im-alter. Accessed 21 Jan 2020.
therapy improves cognitive functions and reduces depressive symptoms in
44. Cuijpers P, Vogelzangs N, Twisk J, Kleiboer A, Li J, Penninx BW. Differential
elderly people with dementia: a meta-analysis of randomized controlled
mortality rates in major and subthreshold depression: meta-analysis of
trials. J Am Med Dir Assoc. 2015;16(12):1087–94.
studies that measures both. Br J Psychiatry. 2013;202:22–7.
22. O’Shea E, Devane D, Murphy K, Cooney A, Casey D, Jordan F. Effectiveness
45. Ebert DD, Buntrock C, Reins JA, Zimmermann J, Cuijpers P. Efficacy and
of a structured education reminiscence-based program for staff on the
moderators of psychological interventions in treating subclinical depression
quality of life of residents with dementia in long-stay units: a study protocol
and preventing major depressive disorder insets: protocol for an individual
for a cluster randomized trial. Trials. 2011;12(41). https://doi.org/10.1186/
patient data meta-analysis of randomised controlled trials. BMJ Open. 2018;
1745-6215-12-41.
8:e018582. https://doi.org/10.1136/bmjopen-2017-018582.
23. Pinquart M, Forstmeier S. Effects of reminiscence interventions on psychosocial
46. Grubaugh AL, Myers US, Keller SM, Wangelin BC, Lozano BE, Tuerk PW. An
outcomes: a meta-analysis. Aging Ment Health. 2012;16(5):541–58.
adjunctive human-animal interaction intervention for veterans with PTSD:
24. Riedel M. Forum “Pferdegestützte Interventionen” Entwicklungsstand,
study protocol for a randomized controlled trial. Trials. 2019;20:786. https://
Terminologie und Zuordnungen. Mensch und Pferd Int. 2011;4:187–9.
doi.org/10.1186/s13063-019-3877-3.
25. Aziz R, Steffens DC. What are the causes of late-life depression? Psychiatr 47. Trzmiel T, Purandare B, Michalak M, Zasadzaka E, Pawlaczyk M. Equine
Clin N Am. 2013;36:497–516. assisted activities and therapies in children with autism spectrum disorder: a
26. Truschel J. Depression definition and DSM-5 diagnostic criteria. https:// systematic review and a meta-analysis. Complement Ther Med. 2019;42:
www.psycom.net/depression-definition-dsm-5-diagnostic-criteria/.Accessed 104–13. https://doi.org/10.1016/j.ctim.2018.11.004.
08 Sep 2020.
27. Chachamovich E, Fleck M, Laidlaw K, Power M. Impact of major depression
and subsyndromal symptoms on quality of life and attitudes toward aging Publisher’s Note
in an international sample of older adults. Gerontologist. 2008;48:593–602. Springer Nature remains neutral with regard to jurisdictional claims in
28. Goldney RD, Fisher LJ, Dal Grande E, Taylor AW. Subsyndromal depression: published maps and institutional affiliations.
prevalence, use of health services and quality of life in an Australian
population. Soc Psychiatry Psychiatr Epidemiol. 2004;39:293–8.
29. Braune BT, Berger K. The influence of depressive mood on activities of daily
living and health care utilization in the elderly – the MEMO study on the
KORA platform Augsburg. Gesundheitswesen. 2005;67:176–9. https://doi.
org/10.1055/s-2005-858236.
30. Cuijpers P, Koole SL, van Dijke A, Roca M, Li J, Reynolds CF. Psychotherapy
for subclinical depression: meta-analysis. Br J Psychiatry. 2014;205(4):268–74.
https://doi.org/10.1192/bjp.bp.113.138784.You can also read
